MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. KARLIN RETRACTOR, CRANK FRAME BODY

Model Number	46-3191
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is in process of being evaluated.The investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges that the device is not working properly, it is not cranking.This occurred during a patient procedure.
Additional Manufacturer Narrative
The device was returned for evaluation.It was confirmed that the device was not functioning as intended.The retractor was cleaned, sterilized, and lubricated after which it functioned correctly as intended.The root cause was insufficient maintenance, especially a lack of or minimal lubrication as outlined in the devices ifu.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: KARLIN RETRACTOR, CRANK FRAME BODY
• Common Device Name: KARLIN RETRACTOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: terry hall ; 3034 owen drive; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22864595
• Report Number: 3007208013-2025-00040
• Device Sequence Number: 9339112
• Product Code: GZT
• UDI-Device Identifier: 00887482014950
• UDI-Public: 00887482014950
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K882071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46-3191
• Device Lot Number: 2235193 SO416533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown